An Open-Label, Two-Part, Two-Period Crossover Study to Determine Bioequivalence Between Nemtabrutinib FFP and FMF2 Formulations & FMF1 and FMF2 Formulations at 65 mg Single Dose in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib
研究概览
简要总结
The goal of the study is to measure and compare the levels of nemtabrutinib in the blood after taking different forms of nemtabrutinib orally on an empty stomach (fasted) to see if they are the same or different.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The key inclusion criteria include but are not limited to the following:
- •Is in good health before randomization
- •Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •Has a history of cancer with pre-specified exceptions (adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, per protocol guidelines)
研究组 & 干预措施
Nemtabrutinib Form A
Participants receive nemtabrutinib form A orally.
干预措施: Nemtabrutinib (Drug)
Nemtabrutinib Form B
Participants receive nemtabrutinib form B orally.
干预措施: Nemtabrutinib (Drug)
Nemtabrutinib Form C
Participants receive nemtabrutinib form C orally.
干预措施: Nemtabrutinib (Drug)
结局指标
主要结局
Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib
时间窗: At designated time points (up to approximately 2 weeks)
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib.
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Nemtabrutinib
时间窗: At designated time points (up to approximately 2 weeks)
Blood samples will be collected to determine the Cmax of nemtabrutinib.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 2 months)
- Number of Participants Who Discontinue Study Due to an AE(Up to approximately 2 months)